Greater Cambridge Area
Seasoned development operations leader with Pharm D degree and completed MBA studies. Has managerial experience at global scale including remote and matrix staff management both in CRO and pharma environment in multiple countries and regions. Has a record on successful team performance improvement, developed business in new territories, developed new organizational structures and roles, lead and participated in implementation of new process and technology projects on a global scale involving 10k+users. Has ability to combine strategic leadership with day to day team leadership with focus on clinical data generation and associated cross functional interdependencies and patient/end-user experience in mind . Co-develop cross functional solutions with peer functions to enable efficient clinical trial execution and data delivery in support of desired filing strategies. Former World Championship medalist and Olympic participant in rowing. Elected as Swim England Cambridgeshire County Chairperson to manage and improve aquatics disciplines in the county.
Accountable for the landscape of processes across Global Clinical Operations. Manage a team of professionals to develop and maintain streamlined, effective , efficient and compliant processes to drive GSK’s R&D strategy. Shape GCO excellence as Leadership member and represent GCO at the Global R&D Process Governance.
Global Process Owner in the Global Clinical Operations organisation accountable for the health for Clinical Safety Document Distribution and developing and E2E User Access Management Process . Leading enabling technology and process improvement projects improving GSK’s ability to accelerate clinical trial execution and further evolve a process to drive automation and compliance for clinical trial systems user access management.
Global Leader of newly formed organization merging the previous Clinical Site Management and Data Management teams conducting clinical trials for Advanced T- Cell therapy. Responsible for delivering clinical trial data through streamlined site and data management activities, ensuring high quality data and data integrity. Maintaining delivery and oversight for clinical trials through a hybrid team of internal roles, FSP and CRO supported delivery. Aligning delivery cross functionally within the broader Clinical Development Operations with peer functions across Medical Development, Medical Affairs, and Quantitative Data Sciences, Translational Sciences, Regulatory, Safety and Manufacturing. Responsible for Site and Data Management strategies and streamlining Clinical Data and Site Operations and evolving the business model to evolve operational efficiency to enable faster high quality data delivery and accelerating access to novel TCR therapy for patients. Focus areas : operational oversight, process and SOP development, clinical data collection standards development , established standards governance , data flow acceleration, operational and data collection system implementation, coaching and mentoring .
Global Leader of Site Management organization conducting clinical trials for Advanced T- Cell therapy. Responsible for delivering clinical trial feasibility and site selection and ensuring high quality and timely delivery and maintaining oversight for clinical trials at investigational sites through a hybrid team of internal roles and CRO supported delivery. Aligning delivery cross functionally within the broader Clinical Development Operations Team and with peer functions across Medical Development, Medical Affairs, Translational Sciences, Regulatory, Safety and Manufacturing. Responsible for various projects expanding Adaptimmune’s Site Management presence to new geographies and streamlining internal operations. As part of this effort established new delivery model (FSP) for Site Management and implemented and integrated in existing system environment the first CTMS for the company, In addition partnered with Head of Data management to redefine and set foundations of updated Clinical SSU requirements for Data Base Build and end to end data flow in support of timely data entry from clinical sites.
Global Development Operations Process Improvement lead responsible for Clinical Study Start up , Conduct and Close out processes in Amgen. Maintain process health, improvements and oversight through a network of Business Process Owners. Leading technology implementation projects across Amgen R&D. Experience includes but not limited to eConsent, Safety, SSU and Clinical portal solutions, Clinical Data base development and enhancements. Represent Amgen at the TransCelerate Biopharma eConsent initiative . Co leading Modernizing Clinical Trial Conduct (MCTC) Transformation Ideation initiative. Amgen delegated advisory board member at Shared Investigator Platform (SIP).
Responsible for Clinical Site Management Operational delivery the following countries: France, Greece, Italy, Portugal, South Africa, Spain, Turkey . Leading process improvement Initiatives including eConsent implementation in Amgen and. co- lead of External Engagement focus group with Transcelerate eConsent initiative ( until June 2017) Country responsibility expanded in to include Poland, Czech Republic, Hungary, Russia, Ukraine until February 2017 Responsible for UK, Ireland, Belgium, Netherlands, Denmark, Norway, Finland, Sweden, Iceland, Latvia, Lithuania, Estonia, France, Spain, Portugal, Greece, Turkey as of February 2017 Working on internal initiative of Next Generation of Risk Based Monitoring from May 2017.
Responsible for Clinical Site Management Operational delivery the following countries: France, Greece, Italy, Portugal, South Africa, Spain, Turkey . Leading process improvement Initiatives including eConsent implementation in Amgen and co- lead of External Engagement focus group with Transcelerate eConsent initiative
Responsibilities covered set up and management of CRA team in a phase II multi center trial for Multiple Sclerosis in Europe. In addition Site Selection Visits in 5 protocols in different inications(Depression, Colorectal cancer, Visceral pain, Cancer pain, Osteoarthritis)
Clinical Team Leader Responsibilities covered activities over the full duration of large multi-national study (phase III), from study start-up covering 15 countries in Europe and Australia Clinical Research Associate (CRA) and Senior Clinical Research Associate (SrCRA) Responsibilities covered activities over the full duration of large multi-national studies (phase II, III), from start-up to project close-out.Therapeutic focus: CNS, Internal Medicine, Immunology